Language Environment in Children With Cochlear Implants (ISLODA)

November 16, 2020 updated by: University Hospital, Montpellier

Influence of Language Environment in Children With Cochlear Implants

The Language Environment Analysis (LENA) system is a specific tool for the language environment analysis. Children aged from 18 months to 6 years old, with cochlear implants (CIs), wear an electronic device during a day and their language interactions are registered. Then the investigators can analyze with a specific software four different parameters (adult words, conversational turns, child vocalizations and media exposure) and compare them to the language ability of the children assessed by a speech therapist. With the results, the speech therapist can advise the parents how to improve the language environment to help their children with CIs for their language development. Parents are encouraged to follow these advices at home during few months (5 months +/-1 month). Then there is a new registration of the LENA device and another language assessment are performed, to see if there is any improvement. The investigators also measure the family participation.

Hypothesis : There is an influence of the language environment measured by the LENA system on language development in children with cochlear implants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Over 24 months the investigators will recruit 90 patients with cochlear implants (CIs) in 2 centers.

Each patient will follow during 5 months and will have three or five visits according to the arm.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Eligibility Criteria:*

Inclusion criteria:

  • Congenital profound deaf children
  • aged from 18 months to 5 years old 11 months
  • with a cochlear implant at least since 6 months
  • regular following in speech therapy

Exclusion criteria:

  • non-francophone parents
  • syndrome (like CHARGE syndrome) or aplasia
  • partial insertion of the electrode array
  • associated troubles (Autism Spectrum Disorders, mental retardation…)
  • visual troubles
  • irregular use of the cochlear implant (externe part)
  • absence of parental consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LENA and advices
With the LENA results, we will advise the parents how to improve the language environment to help their children with CIs for their language development
Behavioral: LENA and advice
Language recording with the LENA device, with the LENA results, we will advise the parents how to improve the language environment to help their children with CIs for their language development
Active Comparator: LENA without advices
Regular speech therapy follow blindly the results of LENA
Other: LENA without advice
Language recording with the LENA device. Regular speech therapy follow blindly the results of LENA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in language environment measured by LENA system
Time Frame: At the inclusion, and 5 months after the inclusion
At the inclusion, and 5 months after the inclusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in language ability measured by the Grammatical Analysis Of Elicited Language Presentence level (GAEL-P)
Time Frame: At the inclusion, and 5 months after the inclusion
At the inclusion, and 5 months after the inclusion
Change in language ability measured by a vocabulary scale with peabody images (EVIP) (EVIP)
Time Frame: At the inclusion, and 5 months after the inclusion
At the inclusion, and 5 months after the inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Collaborators

Hôpital Necker-Enfants Malades

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2016

Primary Completion (Actual)

September 2, 2020

Study Completion (Actual)

September 2, 2020

Study Registration Dates

First Submitted

July 7, 2016

First Submitted That Met QC Criteria

July 29, 2016

First Posted (Estimate)

August 3, 2016

Study Record Updates

Last Update Posted (Actual)

November 18, 2020

Last Update Submitted That Met QC Criteria

November 16, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 9678
  • 2016-A00155-46 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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